Diabetes Dialogue: Sotagliflozin for T1D and Other ADCES 2024 Highlights

This episode of Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives, our second related to the Association of Diabetes Care and Education Specialists (ADCES) 2024 annual meeting, spotlights new data and perspectives from the meeting brought forth by pharmaceutical and diabetes technology companies.

Check out our first episode related to ADCES 2024.

A large theme of the episode is discussion around data and interactions with Lexicon, which announced the resubmission of a New Drug Application for sotagliflozin (Zynquista) as an adjunct to insulin therapy for glycemic control among adults with type 1 diabetes and chronic kidney disease. According to the FDA, the agency considers the resubmission a complete response to its 2019 letter regarding sotagliflozin for type 1 diabetes.¹

For this application, the FDA has assigned a Prescription Drug User Fee Act review date of December 20, 2024. On August 21, 2024, Lexicon Pharmaceuticals announced the FDA’s intention to host an advisory board meeting regarding this application.²

Of note, sotagliflozin (Inpefa) has received approval in heart failure for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors in May 2023.³

Following this, the conversation between hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, shifts to a discussion on Medtronic's collaboration with Abbott, with the hosts praising this partnership as a strategic move to improve sensor technology for patients.

The episode then highlights the innovative educational approach to learning about the Sequel Twiist, with Sequel hosting a jeopardy-style game to engage attendees in learning about their upcoming pump product. Finally, the hosts explore the Diabetotech certificate program, which offers in-depth education on various diabetes technologies, and emphasize the importance of continuous learning and unbiased educational resources in the rapidly evolving field of diabetes management.

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.

References:

1. Lexicon Pharmaceuticals. Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes. Lexicon Pharmaceuticals Media Center. June 21, 2024. Accessed August 21, 2024. https://www.lexpharma.com/media-center/news/2024-06-21-lexicon-pharmaceuticals-resubmits-sotagliflozin-nda-for-type-1-diabetes.
2. Lexicon Pharmaceuticals. Lexicon Pharmaceuticals Announces FDA Advisory Committee Meeting for Zynquista. Lexicon Pharmaceuticals Media Center. August 21, 2024. Accessed August 21, 2024. https://www.lexpharma.com/media-center/news/2024-08-21-lexicon-pharmaceuticals-announces-fda-advisory-committee-meeting-for-zynquista.
3. Campbell P. FDA approves Sotagliflozin for treatment of heart failure. HCP Live. May 26, 2023. Accessed August 21, 2024. https://www.hcplive.com/view/fda-approves-sotagliflozin-for-treatment-of-heart-failure.